This unique program is offered over 4 weeks (one full day per week) and classes can be offered on Saturdays based on the students demand. Please contact info@crownacademy.ca for more information and registration.

This program includes 5 topics:

1- Fundamentals of Drug Development Process and Pharmaceutical Clinical Research

This topic is designed to orient students to the Drug Development Process, the clinical research, functions within the corporate and regulatory context from Canadian and international perspectives. Development of drugs is used as a model.

2- Legislations and International Guidelines for Bio-Ethics in Pharmaceutical Clinical Research

This topic is designed to provide a framework for understanding the standards and regulations related to the clinical research functions. The course will start with a historical overview of such documents as the Nuremberg Code, the Belmont Report and the Declaration of Helsinki. Emphasis will be on the International Conference on Harmonization (ICH) guidelines, and GCP. Additionally, safety related topics as the Tri-Council Policy Statement, the Food and Drugs Act, SAP program and privacy legislation will be discussed.

3- Good Clinical Practices (ICH-GCP)

This topic covers the ICHG-E6 regarding the international guidelines for conducting clinical research

4- Organization of Clinical Trials and Study Monitoring Visits

This topic is designed to outline the various stages of clinical research including activities as they relate to the monitoring of the clinical trial sites. The course will review the progress of a study from the monitor’s as well as a sponsor’s and investigator’s perspectives and highlight the milestones reached throughout the study. Students will learn the management and organizational aspects of site monitoring combined with the quality control and clinical safety measures that ensure the collection of adequate data in addition to ensuring the safety of trial subjects.

5- Clinical Data Acquisition, Data Management and Biostatistics

This topic will provide an introduction to clinical research and drug safety data entry, computer systems, ICH guidelines for electronic data management, methods required in the development of clinical research data analysis.

Clinical research is a branch of health care science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.

The term clinical research refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.

In the United States, when a test article is unapproved or not yet cleared by the Food and Drug Administration (FDA), or when an approved or cleared test article is used in a way that may significantly increase the risks (or decreases the acceptability of the risks), the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc. are submitted in support of an Investigational New Drug (IND) application[1] to the FDA for review prior to conducting studies that involve even one human and a test article if the results are intended to be submitted to or held for inspection by the FDA at any time in the future (in the case of an already approved test article, if intended to submit or hold for inspection by the FDA in support of a change in labeling or advertising). Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption (IDE) application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. In addition clinical research may require Institutional Review Board (IRB) or Research Ethics Board (REB) and possibly Other institutional Committee reviews, Privacy Board, Conflict of Interest Committee, Radiation Safety Committee, Radioactive Drug Research Committee, etc. approval whether or not the research requires prior submission to the FDA. Clinical research review criteria will depend on which federal regulations the research is subject to (e.g., (Department of Health and Human Services (DHHS) if federally funded, FDA as already discussed) and will depend on which regulations the institutions subscribe to, in addition to any more stringent criteria added by the institution possibly in response to state or local laws/policies or accreditation entity recommendations. This additional layer of review (IRB/REB in particular) is critical to the protection of human subjects especially when you consider that often research subject to the FDA regulation for prior submission is allowed to proceed, by those same FDA regulations, 30 days after submission to the FDA unless specifically notified by the FDA not to initiate the study.

Clinical research is often conducted at academic medical centers and affiliated research study sites. These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants.

The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. This has led to a growing field of technologies used for managing the data and operational factors of clinical research. Clinical research management is often aided by eClinical systems to help automate the management and conducting of clinical trials.

In the European Union, the European Medicines Agency (EMA) acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials.